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Anticoagulant
Catheter-directed Thrombolysis for Pulmonary Embolism (HI-PEITHO Trial)
Phase 4
Recruiting
Led By Stavros Konstantinides, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-80 years, inclusive
Objectively confirmed acute PE, based on computed tomography pulmonary angiography (CTPA) showing a filling defect in at least one main or proximal lobar pulmonary artery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights
HI-PEITHO Trial Summary
This trial will compare two ways of treating pulmonary embolism, by either using blood thinners or a device to dissolve blood clots.
Who is the study for?
Adults aged 18-80 with a recent diagnosis of acute pulmonary embolism, at elevated risk of early death or hemodynamic collapse, but not in shock or needing intensive care for other reasons. They must have certain clinical signs like increased heart rate and specific blood test results. Excluded are those who've had major bleeding issues, strokes, certain surgeries recently, severe infections like COVID-19 if it's not the main issue, pregnant women, and people on some chronic medications.Check my eligibility
What is being tested?
The HI-PEITHO study is testing two treatments for pulmonary embolism: standard anticoagulation therapy alone versus anticoagulation plus the EkoSonicTM Endovascular System to break up clots. Participants will be randomly assigned to one of these treatments and monitored over a year through several follow-ups to see which treatment reduces death and complications more effectively.See study design
What are the potential side effects?
Possible side effects include bleeding risks associated with heparin use (like bruising or nosebleeds), potential allergic reactions to device materials or medication excipients used in the trial interventions. The endovascular system might also cause local irritation where it's inserted.
HI-PEITHO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Select...
I have a confirmed pulmonary embolism shown by a CT scan.
HI-PEITHO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiorespiratory decompensation or collapse
PE recurrence
PE-related mortality
Other outcome measures
All-cause mortality
All-cause mortality, cardiorespiratory collapse or recurrence of PE
Cardiorespiratory decompensation
+18 moreHI-PEITHO Trial Design
2Treatment groups
Active Control
Group I: Anticoagulation and EkoSonicTM Endovascular SystemActive Control2 Interventions
Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH) and EkoSonicTM Endovascular System [ultrasound-facilitated catheter-directed delivery of thrombolytic: 2 mg bolus/catheter + 1 mg/hour/catheter for 7 hours (total of 9 or 18 mg]
Group II: AnticoagulationActive Control1 Intervention
Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Pulmonary Embolism (PE) include anticoagulation and thrombolysis. Anticoagulation therapy, such as with heparin or warfarin, prevents further clot formation and allows the body's natural fibrinolytic system to break down the existing clot.
Thrombolysis involves the use of drugs like tissue plasminogen activator (tPA) to actively dissolve clots. The EkoSonicTM Endovascular device enhances this process by using ultrasound waves to facilitate the penetration of thrombolytic agents into the clot, improving the efficiency of clot dissolution.
This combination is crucial for PE patients as it can rapidly reduce the clot burden, improve blood flow, and decrease the risk of complications such as right heart failure and death.
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
723 Previous Clinical Trials
933,349 Total Patients Enrolled
9 Trials studying Pulmonary Embolism
2,126 Patients Enrolled for Pulmonary Embolism
University Medical Center MainzOTHER
20 Previous Clinical Trials
36,996 Total Patients Enrolled
National PERT Consortium, Inc.UNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major surgery or serious injury in the last 3 weeks.Your right-to-left ventricular diameter ratio is 1.0 or higher on a specific type of imaging test called a CTPA.I have been treated with dabigatran or edoxaban for my PE without first receiving heparin for 5 days.I have had bleeding in my brain or eyes at some point.I only take low-dose aspirin or clopidogrel for my chronic condition, not both.I have received a clot-dissolving drug or a specific heart medication in the last 30 days.You are not in the intensive care unit for any reason other than the current issue with your lungs. If you have COVID-19, you can join the study if the doctor thinks the main problem is a blood clot in your lungs and your breathing and heart functions are at certain levels.My blood pressure was low but stabilized within 2 hours without needing strong medications.I am currently experiencing active bleeding.I have taken a daily dose of LMWH or fondaparinux within the last 24 hours.I have not had a cardiac arrest or needed CPR recently.I am at high risk of early death or severe health decline due to new health issues.I have had a stroke or mini-stroke in the last 6 months, or any time before that which left me permanently disabled.You need a special machine called ECMO, or you already started using ECMO before joining the study.My symptoms have lasted more than 14 days.Your blood test shows high levels of troponin I or T.Your blood pressure is consistently lower than 110 mm Hg for at least 15 minutes.You have a temperature higher than 102.2 degrees Fahrenheit.Your breathing rate is very high, or your oxygen levels are low even when resting.You are not expected to live for more than 6 months.I am between 18 and 80 years old.I have a brain tumor or cancer that has spread to my brain.Unstable blood pressure or heart rate.I can't quickly get treatments for a lung clot due to an ongoing epidemic.I am on a long-term blood thinner like apixaban or rivaroxaban.You are allergic to alteplase, LMWH, UFH, or any of the ingredients in these medications.Your platelet count is less than 100 billion per liter.I have taken apixaban or rivaroxaban within the last 12 hours.I am on chronic vitamin K treatment or have a blood clotting disorder with an INR > 1.5.I have a confirmed pulmonary embolism shown by a CT scan.I have experienced shock due to a pulmonary embolism, with low blood pressure and signs of poor organ function.Your heart beats too fast, but not because of low blood volume, irregular heartbeats, or infection.
Research Study Groups:
This trial has the following groups:- Group 1: Anticoagulation and EkoSonicTM Endovascular System
- Group 2: Anticoagulation
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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